A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Официальное название

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Type 2 Diabetes Mellitus (AURORA-2)

Обзор

Study ASC30-302 (AURORA-2) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight and T2DM.

Вмешательства

• Препарат ASC30 tablets A1
  ASC30 tablets A1 administered orally once daily.
• Препарат Placebo
  Matching placebo tablets administered orally once daily.

Первичные конечные точки

• Percent change from baseline in body weight [Срок оценки: Baseline to Week 72]

Вторичные конечные точки (10)

• Change from baseline in HbA1c (%) [Срок оценки: Baseline to Week 72]
• Change from baseline in fasting serum glucose (mg/dL) [Срок оценки: Baseline to Week 72]
• Change from baseline in systolic blood pressure (SBP) (mmHg) [Срок оценки: Baseline to Week 72]
• Percent change from baseline in fasting non-HDL cholesterol [Срок оценки: Baseline to Week 72]
• Percent change from baseline in fasting triglycerides [Срок оценки: Baseline to Week 72]
• Change from baseline in BMI (kg/m²) [Срок оценки: Baseline to Week 72]
• Change from baseline in fasting insulin (pmol/L) [Срок оценки: Baseline to Week 72]
• Change from baseline in waist circumference (cm) [Срок оценки: Baseline to Week 72]
• Change from baseline in diastolic blood pressure (DBP) (mmHg) [Срок оценки: Baseline to Week 72]
• Percent change from baseline in fasting total cholesterol [Срок оценки: Baseline to Week 72]

Критерии участия

Критерии включения

• Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening.
• Have a BMI ≥ 27 kg/m2 at screening.
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
• Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c > 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.

Критерии исключения

• Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
• Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
• Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.
• Have a history of acute or chronic pancreatitis any time prior to screening.
• Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
• Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
• Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07743450 · ASC30-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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